- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02707432
Reducing Cardiovascular Disease Risk Factors in Rural Communities in North Carolina
연구 개요
상세 설명
Cardiovascular disease (CVD), the leading cause of death in the United States (US), disproportionately burdens rural communities. CVD prevalence rates for residents of rural areas (13.1%) is higher compared to those in urban areas (11.2%) of the US. The proposed settings for this research report similar trends in CVD prevalence, where CVD and stroke are among the top three leading causes of death. In community health assessments conducted in the last three years CVD risk factors such as obesity and hypertension were among the top 10 health priorities in our target counties. Compared to residents of metropolitan areas, rural residents have higher rates of cigarette smoking, obesity, mortality from ischemic heart disease, and are physically inactive. These disparities are likely to widen; at the current rate, its estimated 50% of individuals in the US will have CVD by 2030.
Using a community-based participatory research (CBPR) approach, our specific aims for the study are to:
- Expand and sustain a coalition of community and academic stakeholders to develop successful CVD risk prevention strategies in rural communities;
- Conduct a mixed-method community needs and assets assessment based on: a) assemble, review and assess existing sources of CVD data; b) identification of community strengths and resources using a web-based survey of community, faith based, social service and healthcare organizations; c) determine the acceptability of components of CVD risk reduction EBIs and community members' perceptions of possible targets for intervention using focus group interviews; d) determine specific family influences (barriers and facilitators) on acceptability of EBI acceptability;
- Adapt PREMIER, a multi-component EBI using intervention mapping;
- Conduct a small-scale randomized control trial to assess a) efficacy; and, b) feasibility and adaption of implementing adapted PREMIER in rural settings.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
-
-
North Carolina
-
Rocky Mount, North Carolina, 미국, 27801
- Project Momentum Inc.
-
Rocky Mount, North Carolina, 미국, 27891
- Shirley McFarlin
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- African American
- Aged 21 and older
- Has at least one of the following cardiovascular disease (CVD) risk factors: pre-diabetes, hypertension, obesity, family history of early CVD, prior CVD
- Reside in Nash or Edgecombe counties of North Carolina
Exclusion Criteria:
- Evidence of active or unstable CVD
- Cognitive impairment that limits informed consent
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Time 1 (T1) Intervention Group
This group will be the first to receive the adapted intervention, "Heart Matters" (adapted from the PREMIER intervention).
The intervention will be 12 months long.
|
"Heart Matters" is an intervention adapted from PREMIER, an evidence-based, comprehensive lifestyle intervention that focuses on blood pressure as the primary outcome.
To assess the feasibility and efficacy of adapting PREMIER for rural African Americans, Heart Matters will be delivered to multiple intervention groups, but at two different stages.
다른 이름들:
|
|
실험적: Time 2 (T2) Intervention Group
This delayed intervention group will receive the adapted intervention, "Heart Matters," six months after the T1 Intervention group.
The intervention will be 12 months long.
|
"Heart Matters" is an intervention adapted from PREMIER, an evidence-based, comprehensive lifestyle intervention that focuses on blood pressure as the primary outcome.
To assess the feasibility and efficacy of adapting PREMIER for rural African Americans, Heart Matters will be delivered to multiple intervention groups, but at two different stages.
다른 이름들:
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Change in Weight
기간: Baseline and 6 months after initiated treatment
|
Measured in pounds
|
Baseline and 6 months after initiated treatment
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Change in Systolic Blood Pressure
기간: Baseline, Month 6
|
Blood pressure as measured in mmHg
|
Baseline, Month 6
|
|
Change in Diastolic Blood Pressure
기간: Baseline, Month 6
|
As measured in mmHg
|
Baseline, Month 6
|
공동 작업자 및 조사자
협력자
수사관
- 수석 연구원: Giselle Corbie-Smith, MD, MSc, University of North Carolina, Chapel Hill
- 수석 연구원: Mysha Wynn, MA, Project Momentum, Inc.
- 수석 연구원: Shirley McFarlin, BA, James McFarlin Community Development, Inc.
간행물 및 유용한 링크
일반 간행물
- Frerichs L, Bess K, Young TL, Hoover SM, Calancie L, Wynn M, McFarlin S, Cene CW, Dave G, Corbie-Smith G. A Cluster Randomized Trial of a Community-Based Intervention Among African-American Adults: Effects on Dietary and Physical Activity Outcomes. Prev Sci. 2020 Apr;21(3):344-354. doi: 10.1007/s11121-019-01067-5.
- Corbie-Smith G, Wiley-Cene C, Bess K, Young T, Dave G, Ellis K, Hoover SM, Lin FC, Wynn M, McFarlin S, Ede J. Heart Matters: a study protocol for a community based randomized trial aimed at reducing cardiovascular risk in a rural, African American community. BMC Public Health. 2018 Jul 31;18(1):938. doi: 10.1186/s12889-018-5802-1.
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 13-2576
- 5R01HL120690-02 (미국 NIH 보조금/계약)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .